Irex System II 2D/DOPPLER Imaging System
FDA 510(k) K827370 · Irex Corp.
510(k) numberK827370
Submission
- Device name
- Irex System II 2D/DOPPLER Imaging System
- Applicant
- Irex Corp.
Ramsey, NJ, US - Received
- April 12, 1982
- Decision date
- June 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Irex Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K844404 | Irex PS, Portable Scanner and 118IYO · Traditional | 02/04/1985SE |
| K843643 | Color Doppler 880DXK · Traditional | 01/31/1985SE |
| K842408 | Irex 730 Mechanical Sector ScannerJAF · Traditional | 11/29/1984SE |
| K840139 | Irex 720 Sector ScannerIYO · Traditional | 05/09/1984SE |
| K813544 | Irex 2D/DOPPLER Phase Array Imaging Sys.IYN · Traditional | 02/05/1982SE |
| K811246 | Doppler Ultrasound Blood FlowmeterDPW · Traditional | 08/12/1981SE |
| K792525 | Irex CardioplanDQK · Traditional | 12/27/1979SE |
| K791317 | Irex Real Time Phased Array SystemCDP · Traditional | 09/17/1979SE |
| K771372 | System IIDSF · Traditional | 08/04/1977SE |
Questions and answers
When was Irex System II 2D/DOPPLER Imaging System cleared by the FDA?
Irex System II 2D/DOPPLER Imaging System (K827370) received a 510(k) decision of Substantially Equivalent on June 28, 1982, 77 days after the submission was received.